Clinical and Radiographic Evaluation of Intra Bony Defects Following Complete Versus Incomplete Removal of Granulation Tissue in Modified Minimally Invasive Surgical Technique (M-MIST). A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- changes in clinical attachment level
Study Overview
Brief Summary
This study is aiming to compare the clinical and radiographic outcomes after complete versus incomplete removal of granulation tissue during modified minimally invasive surgical technique for management of periodontal intrabony defects in patients with chronic periodontitis.
Detailed Description
Periodontal surgery has been expanding in the world of dentistry throughout the past years, as new techniques are emerging to treat the different and complex periodontal disorders. Surgical procedures in dentistry have undergone major changes to minimize invasiveness. In addition, novel instruments and materials have been made to suit the evolution of the surgical procedures (Cortellini. 2012).
Teeth with deep pockets associated with deep intra-bony defects are a clinical challenge for periodontists, where periodontal regeneration has been proven to be effective in managing the treatment of one-, two-, and three-wall intra-bony defects (Needleman and Tucker 2012;Needleman. 2015).
Harrel and Rees (1995) were the first to introduce the term minimally invasive surgery (MIS). MIS is used to describe the use of smaller and more precise surgical procedures that are possible by using of magnifying instruments, such as operating microscopes and microsurgical instruments and materials (Cortellini. 2012).
The rationale for the development of minimally invasive surgical technique (MIST) includes: reduction of trauma during the surgery, increase in flap and wound stability, improvement of wound primary closure, reduction of surgical time, and minimization of intra-operative and post-operative patient discomfort (Cortellini. 2007).
With the use of MIST, Cortellini and Tonneti (2009) confirmed blood clot protection with the aspects of wound and blood clot stability and primary wound closure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •- systemically healthy patients
- •Age range from 25 -
- •Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy.
- •Vertical 2 or 3 walls Intra-bony defects.
- •Perform and maintain good oral hygiene.
- •Able to come for the follow up appointment's needed
Exclusion Criteria
- •- Smokers.
- •Pregnant patients.
- •patients with poor oral hygiene.
- •Multirooted teeth with furcation involvement.
Arms & Interventions
M-MIST (group A)
M-MIST(incomplete granulation tissue removal)
Intervention: M-MIST (Procedure)
M-MIST (group B)
conventional M-MIST.
Intervention: M-MIST (Procedure)
Outcomes
Primary Outcomes
changes in clinical attachment level
Time Frame: at baseline then 6, 9 and 12 months
It is the distance from the cement-enamel junction to the depth of the pocket.
Secondary Outcomes
- patient satisfaction(12 months post-surgery)
- amount of bone fill(at baseline then at 6, 9 and 12 months)
- patient pain and discomfort(at day of the surgery then at 1 , 3 and 7 days post-surgery)
- changes in gingival recession(at baseline then at 6, 9 and 12 months)
- changes in pocket probing depth(at baseline then at 6, 9 and 12 months)
Investigators
Ahmed Ibrahim
principle investigator
Cairo University